He Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA, for its acronym in English) has begun the evaluation of the marketing authorization of the vaccine against the covid of the Spanish company Hipra, which will hit the market under the name of ‘bimervax‘.
In February, the head of the EMA’s Strategy for Biological Health Threats and Vaccines, Marco Cavaleri, already advanced that the evaluation of this vaccine was “advancing”. “We hope to conclude it very soon,” he specified at a press conference.
delays
The final approval of the HIPRA vaccine has not been meeting the expected deadlines, due to the requirements imposed by the EMA. “The truth is that the EMA is being very demanding, I think that since there are now vaccines we are not at the same time, but today the times are the times of the EMA and we have nothing but respect,” said the minister of science and innovationDiana Morant. In fact, the company hoped to receive the green light for its registration and commercialization in November and to be able to distribute the first doses to the Member States before the end of 2022.
“The date depends on what the EMA says; but we hope and trust that we will have the authorization in November and that the vaccine can be part of the vaccination campaign before the end of the year both in Spain and in the rest of the European Union”, indicated the executive vice president of the company, Elia Torroella, in a meeting with journalists in Brussels (Belgium) in October 2022.
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In July of last year, Morant already thought that in “a few days” the EMA was going to issue its opinion on the vaccine, as he expressed during a breakfast with Europa Press.
In any case, both Hipra and Morant have defended the usefulness of the vaccine. The minister, in fact, stated that what they are doing is working with HIPRA, whose vaccine “is very good” and is presenting “very good results” and all the clinical trials “are going well.”